RF SENSOR

GUDID 10614559102114

RF Sensor, Mega Vac Smoke Evacuator

MEGADYNE MEDICAL PRODUCTS, INC.

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator
Primary Device ID10614559102114
NIH Device Record Key4b35a62a-bc5f-4f2c-978c-266927a703f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRF SENSOR
Version Model Number2250
Company DUNS185444825
Company NameMEGADYNE MEDICAL PRODUCTS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]
GS110614559102114 [Primary]

FDA Product Code

FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL
FYDAPPARATUS, EXHAUST, SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-09-16
Device Publish Date2018-09-04

Devices Manufactured by MEGADYNE MEDICAL PRODUCTS, INC.

30614559100046 - Megadyne2020-09-16 E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Ball Electrode, 5 inch (12.7 cm)
30614559100091 - Megadyne2020-09-16 E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 2.75 inch (7 cm)
30614559100107 - Megadyne2020-09-16 E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, Modified Extended Insulation, 2.75 inch (7 cm)
30614559100114 - Megadyne2020-09-16 E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, Modified Extended Insulation, 2.5 inch (6.35 cm)
30614559100121 - Megadyne2020-09-16 E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Needle Electrode, 2.75 inch (7 cm)
30614559100138 - Megadyne2020-09-16 E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Needle Electrode, Modified Extended Insulation, 2.75 inch (7 cm)
30614559100145 - Megadyne2020-09-16 E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 6.5 inch (16.5 cm)
30614559100152 - Megadyne2020-09-16 E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 4 inch (10.2 cm)

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